Nutrition Blood Outcomes Following Tocotrienol N2B

NCT ID: NCT01858311

Last Updated: 2021-09-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2018-12-31

Brief Summary

A natural form of vitamin E called tocotrienol (TCT) has blood thinning and cholesterol lowering properties, both of which may benefit stroke survivors. This study is being conducted to determine the blood thinning and cholesterol lowering properties of TCT in stroke or TIA (transient ischemic attack, which is also referred to as a "mini-stroke") survivors that are receiving the standard treatment for prevention of recurrent stroke.

Study Hypothesis: Oral TCT decreases the incidence of aspirin and clopidogrel nonresponders, increases the extent of inhibition of platelet aggregation, and decreases LDL without significant side effects in stroke patients.

Detailed Description

In this Phase IIB trial the goal is to determine the effects of orally supplemented TCT on platelet function and cholesterol as well as the safety in patients with TIA (transient ischemic attack) or stroke in addition to the standard treatment for stroke prevention. Recurrent cardiovascular events including stroke, TIA, heart attack, venous thrombosis, pulmonary embolism, systemic embolism will also be recorded. In patients with recurrent stroke, severity of the stroke and stroke size measured from MR (magnetic resonance) or CT (computed tomography) imaging will also be collected. We expect that TCT will inhibit blood clotting and lower cholesterol more than current standard treatment without significantly increasing bleeding risks or other side effects. Future work is planned in a larger TIA/stroke population to examine whether TCT adds to standard medical care in terms of decreasing incidence of stroke and improving outcomes following stroke.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Placebo vehicle

(2) placebo capsules following AM meal and (2) placebo capsules following PM meal.

Placebo Vehicle

Intervention Type: OTHER

Placebo capsules per day (2 in the morning and 2 in the evening)

Tocotrienol capsules (400 mg)

(2) 100mg TCT capsules following AM meal and (2) 100mg TCT capsules following PM meal.

Tocotrienol Capsules

Intervention Type: DIETARY_SUPPLEMENT

Vitamin E TCT capsules- 400mg to 800mg per day (2 in the morning and 2 in the evening)

Tocotrienol Capsules (800 mg)

(2) 200mg TCT capsules following AM meal and (2) 200mg TCT capsules following PM meal.

Tocotrienol Capsules

Intervention Type: DIETARY_SUPPLEMENT

Vitamin E TCT capsules- 400mg to 800mg per day (2 in the morning and 2 in the evening)

Interventions

Tocotrienol Capsules

Vitamin E TCT capsules- 400mg to 800mg per day (2 in the morning and 2 in the evening)

Intervention Type: DIETARY_SUPPLEMENT

Placebo Vehicle

Placebo capsules per day (2 in the morning and 2 in the evening)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with either atherothrombotic, cardioembolic, cryptogenic stroke or TIA (transient ischemic attack) for whom anticoagulation is not indicated
• Enrollment in trial must occur within 6 months of clinical presentation for first stroke or TIA event
• No history of long-term vitamin E supplement (defined as daily oral tocopherol or tocotrienol supplementation at least 6mos; within the past 5 years)
• No current vitamin E supplementation in multi-vitamin

Exclusion Criteria

• Disabling stroke ( Modified Rankin Scale > 3)
• Prior intracranial hemorrhage (excluding traumatic)
• High risk of bleeding (recurrent gastrointestinal, genitourinary bleeding, active peptic ulcer disease)
• Anticipated requirement for long term use of anticoagulation
• Contraindications to antiplatelet agents (bleeding disorder, thrombocytopenia, prolonged INR)
• Irreversible medical condition likely to affect short-term survival or ability to participate in study such as cancer or other chronic disease with predicted survival of less than a year or severe psychiatric or neurologic disease that might complicate evaluation of study outcomes like dementia or schizophrenia
• Pregnancy or women of child bearing age who are not following an effective method of contraception
• Breast feeding
• Unable or unwilling to provide informed
• Unlikely to be compliant with therapy or unwilling to return for follow up frequent clinic visits
• Concurrent participation in another study with an investigational drug or devise
• Other likely specific cause of stroke such as dissection, infectious or noninfectious vasculitis, prothrombotic state

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Malaysia Palm Oil Board

OTHER_GOV

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Andrew Slivka

MD, Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University

Columbus, Ohio, United States

Mount Carmel Health System

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2012H0113

Identifier Type: -

Identifier Source: org_study_id